The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.

NCT03107260 | Completed

• 1 other identifier: PI2015_843_0018
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies. Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.

Conditions

Cerebral Saturation; Cognitive Impairment; Emergencies

Outcome Measures

Primary Outcomes (1)

• Occurrence of POCD

  72 hours

Study Arms (1)

Occurrence of postoperative cognitive dysfunction

OTHER

Other: To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients

Interventions

To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients OTHER

Evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in non-cardiac, thoracic and vascular emergency surgery in patients 65 years of age and older. The occurrence of POCD will be defined by the MMSE decrease of at least 4 points at 24, 48 or 72 hours

Occurrence of postoperative cognitive dysfunction

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Non-cardiac, thoracic and vascular emergency surgery
• Surgery under general anesthesia
• ASA I, II or III
• Simple information without consent
• Patient affiliated to social security

You may not qualify if:

• Inability to understand
• Patient under tutelage, or curatorship or deprived of public right
• ASA IV
• History of severe dementia MMSE \<20
• Personal or familial history of malignant hyperthermia
• History of allergy or hypersensitivity to anesthetic products used
• Contra-indication to Cisatracurium®: myasthenia gravis
• Contra-indication to Sevoflurane®
• Contra-indication to local anesthetics
• Indication of use of a Ketamine®-type hypnotic (modification of the BIS)
• Indication of use of nitrous oxide
• History of cranial trauma
• Neuromuscular pathology
• Spinal anesthesia
• Cardiac, thoracic or vascular surgery

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Emergencies

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: January 15, 2016
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

FR (1)